CABA-201 for Inflammatory Myopathies

Recruiting at 24 trial locations

Overseen By Cabaletta Bio

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Cabaletta Bio

Disqualifiers: Severe infections, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

24 Participants Needed

Trial Summary

What is the purpose of this trial?

RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Research Team

Medical Director

Principal Investigator

Cabaletta Bio

Eligibility Criteria

This trial is for adults aged 18-65 with active idiopathic inflammatory myopathy (IIM), including conditions like dermatomyositis and antisynthetase syndrome. Participants must have evidence of ongoing disease despite treatment, shown by muscle weakness or tests like MRI. Excluded are those with severe reactions to the study drugs, active infections needing treatment, major organ issues, previous CAR T cell therapy, or any transplants.

Inclusion Criteria

I experience muscle weakness.

I am between 18 and 65 years old.

My condition is active despite treatment, shown by tests like MRI or high CK levels.

Exclusion Criteria

I am currently being treated for an infection.

I cannot undergo leukapheresis due to health reasons.

I have received CAR T cell therapy before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preconditioning

Participants receive preconditioning with fludarabine and cyclophosphamide

1 week

Treatment

Participants receive a single infusion of CABA-201

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

156 weeks

Treatment Details

Interventions

• CABA-201

Trial Overview The trial is testing CABA-201 after patients receive fludarabine and cyclophosphamide preconditioning. It's an open-label study which means everyone knows they're getting the experimental treatment and there's no placebo group.

Participant Groups

Group I: CABA-201 Experimental Treatment 1 Intervention

DM Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide preconditioning in subjects with DM. ASyS Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide preconditioning in subjects with ASyS. IMNM Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide preconditioning in subjects with IMNM. JIIM Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide preconditioning in subjects with JIIM.

CABA-201 is already approved in United States for the following indications:

Approved in United States as CABA-201 for:

• None approved; under investigation for systemic lupus erythematosus, myositis, systemic sclerosis, myasthenia gravis, and pemphigus vulgaris

Who Is Running the Clinical Trial?

Cabaletta Bio

Lead Sponsor

Trials

6

Recruited

140+